Actively Recruiting
The Effect of Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Led by Tanta University · Updated on 2026-02-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of levothyroxine treatment on heart function in children aged 4 to 15 years with subclinical hypothyroidism, a condition marked by high thyroid-stimulating hormone (TSH) levels but normal thyroxine (T4). Subclinical hypothyroidism can impair heart function and increase various cardiovascular risks such as blood vessel problems and fluid around the heart. Children in the study are randomly assigned to one of two groups: one group will receive levothyroxine treatment starting at a dose of 2 micrograms per kilogram per day, with doses adjusted every 4 weeks to maintain normal TSH levels. The other group will receive no treatment. The study monitors the effects over a 3-month period after starting treatment. Participants will undergo assessments of heart function, specifically measuring the left ventricle's systolic function and fractional shortening three months after treatment begins. The study team will collect data on these heart measurements to evaluate how levothyroxine treatment might influence cardiac health in children with this thyroid condition. The total duration of participation is at least three months following treatment initiation.
CONDITIONS
Brief Title
Levothyroxine Treatment on Cardiac Function in Children With Subclinical Hypothyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 4 to 15 years
- Both sexes
- Stable elevated thyroid-stimulating hormone (TSH) of 4.5 mIU/L or higher with normal free T4 and FT3 in two measurements 4 to 6 weeks apart
You will not qualify if you...
- Overweight and obesity
- Hypertension
- Previous use of levothyroxine, antiepileptic drugs, or cardiac drugs within the last 6 months
- Arrhythmia
- Congenital or acquired heart disease
- Liver or kidney disease
- Hyperlipidemia
- Diabetes
- Infectious diseases
- Respiratory diseases
- Malignancies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive L-thyroxine treatment with dose titration every 4 weeks until a normal thyroid-stimulating hormone (TSH) level is maintained, or participants receive no treatment if assigned to the control group.
Visits every 4 weeks during treatment
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
Z
Zeinab E Elshareef, MBBCH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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